title: Efficacy of spraying l-menthol solution during endoscopic treatment of early gastric cancer: a phase III, multicenter, randomized, double-blind, placebo-controlled study.
abstract: BACKGROUND
  The topical antispasmodic agent l-menthol is useful for inhibiting gastric peristalsis during diagnostic upper gastrointestinal endoscopy. However, it remains unclear whether l-menthol is similarly effective during therapeutic endoscopy, thereby improving treatment outcomes in a clinical setting.
  
  
  METHODS
  A total of 83 patients scheduled to undergo endoscopic treatment at 8 Japanese referral centers were randomly assigned to receive l-menthol or placebo. The degree of gastric peristalsis (peristaltic score: grade 1-5) was assessed by an independent committee. The primary outcome was the proportion of subjects in whom no or mild peristalsis (grade 1 or 2) was maintained throughout endoscopic treatment. Secondary outcomes were the duration of sustained response and the incidence of adverse drug reactions.
  
  
  RESULTS
  The proportion of patients with no or mild peristalsis was significantly higher in the l-menthol group (85.4 %, 95 % confidence intervals 70.8-94.4: 35/41 subjects) than in the placebo group (39.0 %, 24.2-55: 16/41; P < 0.001). The sustained response rates in the l-menthol and the placebo were, respectively, 90.0 and 39.6 % 30 min post-dose, and 79.9 and 35.7 % at the completion of the resection. The sustained response rates were significantly higher in the l-menthol group than in the placebo group (P < 0.001, log-rank test). The incidence of adverse drug reactions did not differ significantly between the two groups (P = 1.000).
  
  
  CONCLUSIONS
  During gastric endoscopic submucosal dissection, spraying l-menthol on the gastric mucosa significantly suppressed peristalsis, with minimal adverse drug reactions as compared with placebo. l-menthol solution might be useful for therapeutic endoscopy.
authors.affiliation: Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan, mtfujish-kkr@umin.ac.jp.
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Fujishiro
authors.forename: Michio
authors.initials: M
authors.lastname: Kaminishi
authors.forename: Naoki
authors.initials: N
authors.lastname: Hiki
authors.forename: Ichiro
authors.initials: I
authors.lastname: Oda
authors.forename: Junko
authors.initials: J
authors.lastname: Fujisaki
authors.forename: Noriya
authors.initials: N
authors.lastname: Uedo
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Kaise
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanabe
authors.forename: Mikitaka
authors.initials: M
authors.lastname: Iguchi
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Matsuhashi
authors.forename: Sachiyo
authors.initials: S
authors.lastname: Nomura
authors.forename: Hisao
authors.initials: H
authors.lastname: Tajiri
authors.forename: Naohisa
authors.initials: N
authors.lastname: Yahagi
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Suzuki
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects* / Q000473:pathology; D006801:Humans; D007564:Japan; D008297:Male; D008610:Menthol / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010528:Peristalsis / Q000187:drug effects; D013274:Stomach Neoplasms / Q000473:pathology / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D008610:Menthol